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A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

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ClinicalTrials.gov Identifier: NCT02503189
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome

Condition or disease Intervention/treatment Phase
Dry Eye With Sjögren's Syndrome Drug: KCT-0809 ophthalmic solution Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KCT-0809 Drug: KCT-0809 ophthalmic solution
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Score of the corneal staining [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Score of the conjunctival staining [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Dry eye patients with Sjögren's syndrome
  • Corneal and conjunctival damage

Exclusion Criteria:

  • Severe ophthalmic disorder
  • Punctal plugs or surgery for occlusion of the lacrimal puncta

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503189


Locations
Japan
Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02503189     History of Changes
Other Study ID Numbers: KCT1301
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Dry eye syndromes
Corneal diseases
Conjunctival diseases

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Sjogren's Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions